I'm I reading this Right?
Are you saying that you think e-Cigarettes are Somehow going to End Up as Medical device to be Used as a Cessation Tool?
I must Not be reading this right.
FDA Zeller Actually Lets the Truth Slip Out - Let's Pay Attention
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I'm I reading this Right?
Are you saying that you think e-Cigarettes are Somehow going to End Up as Medical device to be Used as a Cessation Tool?
I must Not be reading this right.
I've been seeing this BS sentiment around a lot recently:
I maintain that honesty and truth is the only way forward. You can't beat politicians and charlatans at their own game. But truth, and an informed public... sometimes that is enough.
Don't talk to much about how effective ecigs are at getting people away from smokes, cause then PHARMA and regs and etc
I maintain that honesty and truth is the only way forward. You can't beat politicians and charlatans at their own game. But truth, and an informed public... sometimes that is enough.
Telling stories of how vapourizers caused smoking cessation is not the same as making a claim that they are for smoking cessation. The latter is claiming that it has been tested for that very reason. Lots of people start for different reasons.
It was only yesterday that BP was the giant threat and we were all going to be vaping prescription liquid that tasted like spit and toothpaste from things that resembled pink plastic tampon covers. For $60 a 'quit cycle'.
No idea if BP still has a horse in this race because anything can happen, but it's been a catch-22 from the start.
No idea if BP still has a horse in this race because anything can happen, but it's been a catch-22 from the start.
Surely it was sarcasm?
Must be.
Because the Road to go Down to Sell a FDA Approved Smoking Cessation Device is Much More Costly than just selling it as a Tobacco Device. And the Tax Structure is all Wrong for Medial Devices.
e-Cigarettes are going to be Sold as just what they are. An Electronic Cigarette. And they Are Going to Tax the Living Daylights out of them.
About the Only thing I wonder about is Liquid e-Liquids. And if the FDA will follow mg limits like the EU has. And how Soon after the Public Comment Period is over will they Act on whatever they are going to do.
But Nobody seems to want to Talk about e-Liquids Much. Seems that the Only thing people are Worried about is the Hardware.
Yes, you heard me right. I believe the long-term objective - or at least the likely endpoint - is that vaping will become a cessation tool, available by prescription only - and outlawed recreationally (at least insofar as nicotine is involved).
This is not as crazy as one might think. Allowing vaping exclusively for (medical) cessation therapy was part of the EU's original TPD. Two UK firms have already applied to NHS's MHRA for just that - BAT and NicoLite. (That's fairly old news, I don't know whether others have joined or what the current status is.)
In the US, this is what I anticipate:
1) Once the FDA proposed rule becomes final and the 2-year window (or whatever window it is) ends, then only cigAlikes will be left, because only the cigAlike manufacturers will be able to pony up the funds for an application. We're talking about BT's cigAlikes plus maybe NJoy, LOGIC, perhaps one or two others. I can't see any other manufacturers applying, but if they do, their applications can be swatted away.
2) The FDA will not act on the cigAlike manufacturers' applications for a while. That's what it might take to accumulate the data. We all know that cigAlike users are dual users. All the FDA has to do, is to be able to prove it. For once - they won't need junk science or junk statistics. The evidece will be clear and unequivocal. Because cigAlike users still smoke tobacco cigarettes, cigAlikes are a net negative for public health. Why? About 5% of them would completely quit tobacco cigarettes annually, were cigAlikes not available. We've already heard people like Frieden and McAfee and Zeller say something like this, without specifically mentioning cigAlikes. Glantz says it too: "E-cigarettes lead to more [tobacco cigarette] smoking, not less."
3) At some point, perhaps 3-5 years from now, the cigAlike data will come in, and they'll be pulled from the market - all applications are rejected due to the net negative impact on public health. BT may have bought out the other cigAlike manufacturers by this point. Who will bother suiing the FDA? No one has the incentive to do so. Besides, the FDA will have acted properly, under the statutory standards. They will have done precisely what Congress envisioned - kept a product off the market that has a net negative public health impact.
4) Around the same time, BP will apply for using vaping as cessations. No, I'm not suggesting BP will want to use cigAlikes as a cessation technology, because we know that cigAlikes don't work. Well, what does work? We all know what works. Advanced devices, such as the ones we use. I don't know what precisely BT's version will be. But right now, we can well imagine that somethig as simple as (say) giving the user the choice between a Vivi Nova and a Protank (i.e. a few clearos) and equipping them with a humble spinner might just do the trick. Do you genuinely need a Provari and a IGO-W3 with a quad coil build - if you really want to quit? I'm not talking about what makes you happy, or your "ideal" situation. I'm asking you whether you'd rather smoke tobacco cigarettes, or use a clearo with a spinner? (Especially if you don't know of any third choice.) All smokers need is something that's a cut above a cigAlike. BP will be right there, to satisfy the need. At a hundred times the price.
5) By this point, water-soluble nicotine is now legally available by prescription only. So now the DEA can list it as a schedule II controlled substance (no legislation needed). Just as with previous transitions between the legal and illegal status of a certain drugs, there will be an amnesty period. Turn over the water soluble nicotine to the gov't or destroy it. After that, you'll be guilty of a felony for possessing it w/o a prescription. We've been through this before, with other drugs, haven't we? Go back to the turn of the 20th century.
6) No legislation is required to do any of this. The FDA and the DEA could do it, all by themselves - under their existing authority.
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What's not to like? Everyone's happy now. BT gets to keep sellling stinkies without any real competition, and gov'ts collect the taxes. BP gets to control the vaping market, and gets a much better source of income than it might ever have gotten from NRT, even if vaping hadn't come along to squeeze the NRT market. (BP does not like competition - no more than BT does.)
Vapers will persist as a small, huddled group of stealthy clubbers. 0% nic. vaping will still be legal ... but doing it openly - such as in your own back yard - will be risky. Because if the neighbors call the cops, your house will get searched for illegal liquid nicotine. (Which will be a great annoyance even if you don't have any.) And they'll bring in a HAZMAT team, and start swabbing your walls for residue. If they find any, they'll treat your house as a toxic waste site. It will be torn down, and disposed of by government contractors - at your expense.
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Who knows, maybe not all of this will happen. But BP Would definitely like to get their hands on a cessation technology that works. And they do not want to share it with a bunch of people who aren't paying what they want to charge for it.
This is exactly what you hear from the public health people in the UK and quite a few in the US. They say that vaping could save millions of lives - under the direction of a clinician.
What in the world do we all think that they mean by that??
This a completely rational progression.
Which is why the long-view is to effect new law itself. May take a while; a long while, but with enough grassroots support who knows. I mean, hemp is returning to the US... this against the entrenched power of Big Ag and Big Oil.
While I agree it would be not be very bright for BP not to be on the wagon for a Vapourizer to become a NRT except if successful it may not be a long term investment if everyone quits.
As for UK health. All I've read is vapourizers with support could be more effective not unlike NRTs now.
As for UK health. All I've read is vapourizers with support could be more effective not unlike NRTs now.
OK... Didn't Quite see that One Coming.
I see you have given this a Lot of Thought. Perhaps you can Clear up Couple of Questions that I have.
1 - Which will bring in More Sate and Federal Tax Revenue? A Sales Taxable, normally priced e-Cigarette? Or a FDA Approved Medical Device?
2 - Once All those e-Cigarette Tax Dollars start rolling in, do you think there is going to much City, State or Federal Support to Quash e-Cigarettes?
3 - As More and More People use e-Cigarettes, and More and More Studies are Done that shows that there are Limited or Very Little Adverse effects from using an e-Cigarette, will this Help or Hurt the FDA "Plan" to Short Change BT out of the e-Cigarette Market?
4 - Is BT going to just Sit Back and Allow all this to Happen? BT has some of the Best Lawyer in the World. And isn't there some Legal Precedent that say Americans have the "Right" to use Tobacco Recreationally?
5 - Why would BP want to Spend the Hundreds of Millions of Dollars to be a Part of all this Subterfuge? Wouldn't it just be Cheaper and Faster to just make their own e-Cigarette?
---
Maybe your Right. Maybe there is some "10 Year Plan" to shift a 5+ Billion Dollar Industry into the Hands of BP?
Just seems like there is Going to be a Few Hurdles that may need to be Overcome. But Who Knows.
And if your Right, I'll tell Everyone I heard it Here First.
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I gotta admit, Roger, it doesn't sound crazy at all (except for the hazmat teams). I wish it did. That's why Senator Burr didn't want to put tobacco regulation under the FDA. Since the FDA's mission is to prove the safety and efficacy of the products they regulate, that would never happen with any tobacco product (plus he didn't think they had the resources to do the job anyway). He and Senator Hagan proposed an amendment to the FSPTCA which, among other things, would have established a new harm reduction center in HHS which could focus on tobacco harm reduction.
From the Congressional Record, 111th Congress, page S6146:
Senator Burr: "I have constantly described and made the point that if you don't move people from cigarettes to other tobacco products that allow them to make that transition, you will not reduce death and disease. I don't think tobacco is safe, but I do believe there are products that are safer than smoking . I believe that for adults who choose to use tobacco products, they should have every option available to make sure that that product is something they can access. Compared to smoking , they do reduce death and disease."
He went on to talk about snus and Camel Orbs (dissolvable tobacco) as harm reduction options. I haven't read enough of the Congressional Record yet to see if he discussed the 2009 iteration of e-cigarettes also.
From the Congressional Record, 111th Congress, page S6146:
Senator Burr: "I have constantly described and made the point that if you don't move people from cigarettes to other tobacco products that allow them to make that transition, you will not reduce death and disease. I don't think tobacco is safe, but I do believe there are products that are safer than smoking . I believe that for adults who choose to use tobacco products, they should have every option available to make sure that that product is something they can access. Compared to smoking , they do reduce death and disease."
He went on to talk about snus and Camel Orbs (dissolvable tobacco) as harm reduction options. I haven't read enough of the Congressional Record yet to see if he discussed the 2009 iteration of e-cigarettes also.
The market was carved up over a year ago. Only I think low level bt cigalikes will remain available, as long as they are single use cartridges and don't work to stop smoking very well. The ones that do work are bp's and strictly controlled. This is why no one seems to recognize the vaping industry (as we know it) exists. The only ecigs in existance are cigalikes. FDA / CDC claims 2/3rd of vapers are dual users. 2/3rd's of the countable market are cigalikes (they don't count vape shope, imports and sources we use).
We don't exist.
I don't think they will wait 2 years. I think they feel entittled to the market now and have waited long enough.
FDA has already approved flavors in NRT and they have already gotten FDA's appoval for long term use and dual useages for NRT's. The ecig industry has taken a big bite out of NRT's, which they feel is like "stealing" theri profits.
I think there's a plan that applications will be denied immediatley and products will be pulled.
We don't exist.
I don't think they will wait 2 years. I think they feel entittled to the market now and have waited long enough.
FDA has already approved flavors in NRT and they have already gotten FDA's appoval for long term use and dual useages for NRT's. The ecig industry has taken a big bite out of NRT's, which they feel is like "stealing" theri profits.
I think there's a plan that applications will be denied immediatley and products will be pulled.
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I've only read some of the presentation but I do agree it appears he is sincere about hem reduction. I like his proposal for a separate agency for it
While I don't think all e cigs will get pulled immediately, as the FDA is quite aware of the costly legal battle that would ensue with BT, I agree the vapourizers with the most potential will be killed off with "incorrectly or incomplete" filings
Umm... so the Soterra ruling that they cannot be regulated as medicine/pharmaceutical products doesn't exist in this scenario at all? 
Wow, thank you for pointing out that document. It gives some real background before the enactment of the FSPTCA and I must say that Senator Burr was on point with several of his "what will happen" scenarios. Scary stuff when applied to the current Deeming Regulations.
Umm... so the Soterra ruling that they cannot be regulated as medicine/pharmaceutical products doesn't exist in this scenario at all?
I thought that only applied IF the claim was made that they were a smoking cessation device? Not sure.
If a large pharma was to take a eGo type device with say a Mini Pro Tank type device and pay for the clinical trials, and research. And find out from the research that wonders of all wonders, e-cigs actually work. At that point wouldn't they pretty much own the market, especially if the FDA is glacially slow in approving any e-cig.
Just throwin' it out there...don't put us in the tin foil hats....
Q1) - Which will bring in More Sate and Federal Tax Revenue? A Sales Taxable, normally priced e-Cigarette? Or a FDA Approved Medical Device?
A1) You pose a false choice. Let's break it down. During the FDA's "window", vaping will be taxed, no question. But after the window closes, and only cigAlikes are present, many vapers will either buy cigAlikes and tobacco cigarettes, or just buy tobacco cigarettes. No problem, gov't is still collecting tobacco excise taxes. Once cigAlikes are pulled, they all go back to smoking tobacco cigarettes, unless they can afford the ridiculous fees that BP will charge them for vaping technology. Besides, doesn't BP pay taxes to governments at all levels - directly or indirectly? The revenue is still there. It doesn't have to all be in the form of a tobacco excise tax. One way or another, the gov't is still much better off than it is right now.
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Q2) - Once All those e-Cigarette Tax Dollars start rolling in, do you think there is going to much City, State or Federal Support to Quash e-Cigarettes?
B2) I don't know what you mean by "quash?" Do you mean usage restrictions such as indoor/outdoor vaping bans? Those don't seem to be a much of a problem now with tobacco cigarettes, do they? Do you mean banning internet sales? What does that have to do with what I'm talking about? (Anyway tobacco cigarettes are already unavailable over the internet.) We've already talked about taxes. Again, I just don't see where you're going here, as far as addressing my scenario.
***
Q3) As More and More People use e-Cigarettes, and More and More Studies are Done that shows that there are Limited or Very Little Adverse effects from using an e-Cigarette, will this Help or Hurt the FDA "Plan" to Short Change BT out of the e-Cigarette Market?
A3) Let's step back and look at the law. Zeller and the FDA can sing the praises of vaping all day long. But the statute doesn't let them say "Wow, vaping is great! Let's approve it!".
They have to go product-by-product. Each piece of hardware, each e-liquid (down to the nic. strength, the bottle size, etc.) has to be individually approved via its own application. So if there are no applications, or the applications don't have the proper health studies to support them - whammo! - off the market they (eventually) go. I say "eventually" because of the 2-year window, of course.
What I'm saying is basically what CASAA and many others have already said - namely, that only cigAlikes made by BT will be able to survive the initial part of this prociess - only these deep-pocketed manufacturers will be able to submit an application. Do you think Halo is going to spend $1M or even $100K per combination of e-liquid flavor, nic. strenth, bottle size, etc.? You read the FDA's own economic analysis, right?
Next step - you (implicitly) ask how are the studies going to help the FDA ban cigAlikes? Remember what we're talking about here: a net negative public health impact.
You keep talking about "e-cigs" as a broad class of products. And I keep on trying to explain that this is not how the law works.
If a particular type of cigAlike has mostly dual users - people who still smoke tobacco cigarettes - then it's a loser. Right? Because about 5% of tobacco cigarette smokers quit every year (that's been constant for a long time). So the FDA can and will be able to say that this particular cigAlike has a negative impact on public health, even if e-cigarettes as a whole are great, and even if this paritcular cigAlike is completely harmless in itself ... except for the fact that it prevents users from quitting smoking tobacco cigarettes.
The FDA doesn't have to show that a specific user didn't quit, all they need to do is to look at population statistics. If they find that users of this type of cigAlike tend to quit smoking substantially less frequently than non-users of cigAlikes, then that's all they need. Because reduced smoking of tobacco cigarettes is NOT a health benefit for a given person, according to the public health establishment. A "dual user" is still a SMOKER, and there is only one kind of SMOKER. Therefore this type of cigAlike leads to what Glantz calls "more [tobacco cigarette] smoking, not less."
So now we have more smokers than we would have had without this particular type of cigAlike. Game over. That's exactly what Zeller was saying, and it's how this thread got started. We already know this about cigAlikes. People who use them rarely quit.
But-but-but ... why don't those cigAlike users move up to a Protank? Sorry, no protanks. After the "window" is closed, there will only be cigAlikes on the market. So now these cigAlike users are stuck using cigAlikes and supplementing them with tobacco cigarettes. Bingo, game over. FDA wins, public health impact is negative.
***
Q4) - Is BT going to just Sit Back and Allow all this to Happen? BT has some of the Best Lawyer in the World. And isn't there some Legal Precedent that say Americans have the "Right" to use Tobacco Recreationally?
A4) What is BT going to do about it, if the FDA is doing exactly what Congress told them to do? Americans still have the right to use tobacco recreationally - there are all those grandparented products from before 2007. Just because no "new" products are introduced, means nothing. Besides, if the end point of this process is that BT still gets to sell stinkies with no competition, what's the problem for them?
You keep on talking in vague generalities. And I keep trying to bring us back to the law. To the fact that each product must be individually approved, under the FSPTCA. This is not about whether e-cigarettes as a whole are good, or even whether they are (in themselves) harmless. (Remember what Zeller said. That's how this thread got started.)
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Q5) Why would BP want to Spend the Hundreds of Millions of Dollars to be a Part of all this Subterfuge? Wouldn't it just be Cheaper and Faster to just make their own e-Cigarette?
A5) Because first of all, BP doesn't make recreational products, especially those that involve drugs. That's just not what they do. (Can you imagine them manufacturing beer?) More importantly, we all know how much stuff costs in a hospital? Good grief. Why would BP sell a 30ml bottle of e-liquid for $20 when it can sell a 3ml sealed cartridge for $50 or more, and charge an insurance company which will happily pay that inflated price? Why would BP sell a vivi nova tank for $5 or $10, when it can sell a standalone atomizer for $500 as part of a cessation kit, and some hospital or clinic can charge an insurance company $250 for the technician who shows the patient how to use it? Isn't that how health care works?
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Q6) Maybe your Right. Maybe there is some "10 Year Plan" to shift a 5+ Billion Dollar Industry into the Hands of BP?
A6) This is the same natural progression that we've seen with drugs before. Many drugs that were once freely avaialble and sold for recreational use are now available at ten or a hundred times the price, by prescription only. Furthermore, the scenario I envision is in many ways the inevitable outcome of the FDA's proposed rule and the workings of the law. BP would be very stupid indeed not to take advantage of this opportunity. And they are not stupid.
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Q7) And if your Right, I'll tell Everyone I heard it Here First.
A7) Sorry, but I can't take credit for it. We've already heard it from scores of health professionals who have sung the praises of e-cigarettes. Maybe all of us just didn't know what they meant, when they said that vaping could save lives, if administered under the directlion of a clinician.
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I thought that only applied IF the claim was made that they were a smoking cessation device? Not sure.
If a large pharma was to take a eGo type device with say a Mini Pro Tank type device and pay for the clinical trials, and research. And find out from the research that wonders of all wonders, e-cigs actually work. At that point wouldn't they pretty much own the market, especially if the FDA is glacially slow in approving any e-cig.
Just throwin' it out there...don't put us in the tin foil hats....
I think the tin foil hat is in some bin somewhere? But it's ... it's ... c-coming b-ba ...
[Ah <regaining composure> never mind, let's sort this out quick, before it's too late! ;-)
Exactly right, Stosh. If BP were to submit a successful application for approval as cessation therapy then Soterra would be irrelevant.
Sonic, Soterra only says that the FDA can't just zap e-cigs as an unathorized medical device or drug/therapy/medical_whatever, merely because they contain nicotine, which was the FDA's argument. In other words, the FDA said nicotine is a drug, therefore e-cigs are a drug which is not being sold as part of an approved medical thing (whether that's a drug, device, or therapy combination, I don't recall - which is why I said "thing"
The second aspect of Soterra suggests that if e-cigs were sold as unapproved cessation therapy, then the FDA could zap them. But - as Stosh correctly points out - Soterra says nothing about an approved cessation therapy. However the FDA was not (I believe?) arguing that the e-cigs were actually sold as cessation, so this part is not essential to the result.
There's a third part of Soterra, which is to suggest that the FDA could theoretically regulate vaping as a tobacco product, provided there's something that's derived from tobacco.
Only the first item is technically the "holding." The rest is "dicta" - meaning, technically irrlevant observations about the law which are not needed to get to the result. The main result is just the first part.
You might be Right. I have No Crystal Ball as to what will happen. So I Can't say that you are Wrong.
But one thing to consider. It is Very Hard to Project out more than 4 or 5 Years when it Comes to the way Government Winds blow.
Perhaps when enough time has Pasted for the Events that you have outlined to transpire there will be a Republican President about to take Office? And his 1st Senate address will be before a Republic held Senate?
It is Very Difficult to say what Our Next Presidents Appointees will Look like. Let alone the Term After that. And who will be Holding a Senate Majority is just a Dartboard Guess at Best.
Dynamics, Priorities and Laws all Change with Time.
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